Clinical Trials Logo

Filter by:
NCT ID: NCT01023308 Completed - Multiple Myeloma Clinical Trials

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

PANORAMA-1
Start date: December 21, 2009
Phase: Phase 3
Study type: Interventional

Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore, clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile. Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated MM whose disease has recurred or progressed.

NCT ID: NCT01023295 Completed - Clinical trials for Polypoidal Choroidal Vasculopathy

Study Evaluating the Safety and Response of Fosbretabulin in Asian Patients With Polypoidal Choroidal Vasculopathy (PCV)

Start date: July 2009
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to examine effects of fosbretabulin tromethamine (fosbretabulin) on PCV as reflected by a change from baseline in the number of polypoid lesions on indocyanine green angiography (ICGA).

NCT ID: NCT01020500 Completed - Muscle Spasticity Clinical Trials

To Document the Effectiveness of BoNT-A Injection in Adult Subjects With Upper Limb Spasticity Following Stroke

ULIS2
Start date: January 2010
Phase:
Study type: Observational

The purpose of the study is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one BoNT-A injection cycle in accordance with routine practices.

NCT ID: NCT01020136 Completed - Healthy Volunteer Clinical Trials

A Bioequivalence Study Of AG-013736 Tablets Under Fed Conditions In Healthy Volunteers

Start date: January 2010
Phase: Phase 1
Study type: Interventional

The purpose is to show that 5 mg Form IV tablet of AG-013736 produces similar drug concentrations in plasma compared to 5 mg Form XLI tablet of AG-013736 after oral dosing under fed conditions.

NCT ID: NCT01020071 Completed - Glaucoma Clinical Trials

Prospective Evaluation of the Efficacy of Pascal Laser Iridotomy and Pascal Laser Peripheral Iridoplasty: A Pilot Study

Start date: April 2009
Phase: N/A
Study type: Interventional

Objective: The main objective of this study is to evaluate the efficacy of Pascal Laser Iridotomy and Pascal Laser Peripheral Iridoplasty in lowering intraocular pressure and opening up the angles in patients with narrow angles, primary angle closure and primary angle closure glaucoma. The specific objectives are to evaluate the pain and inflammation associated with the procedure and its possible adverse effects on the lens and corneal endothelium. Study Design: Prospective, interventional case series Study Population: Healthy males and females with appositional angle closure aged 21 y/o and above Methods: Potential participants are evaluated by a glaucoma specialist in National University Hospital. If they are identified as having appositional angle closure they are invited to participate in the study and assigned to either iridotomy or iridoplasty depending on the mechanism of angle closure present. Pupil block for Pascal Laser Iridotomy and plateau iris and angle crowding for Pascal Laser Peripheral Iridoplasty. If they agree to participate they will undergo visual acuity, slit lamp examination, intraocular pressure determination by Goldmann Applanation Tonometry, gonioscopy, optic nerve head evaluation by indirect ophthalmoscopy and lens evaluation by LOCS III opacity grading system. Humphrey visual field examination using 24-2 SITA standard algorithm and stereodisc photos will be obtained if not done within the past 12 months. Anterior segment OCT and laser flare meter will also be performed prior to the procedure. Enrolled patients will be divided into 2 groups. The first group will be assigned to Pascal Laser Iridotomy. The primary mechanism of angle closure in this group is pupillary block. The second group will be assigned to Pascal Laser Peripheral Iridoplasty. This group has non-pupil bock mechanisms which include plateau iris or angle crowding. After the laser procedure, follow-up examinations will be done 1 hr post laser, 1 week, 1 month, 3 months and 6 months. Outcome Measures: The primary outcome measures are the intraocular pressure difference pre and post laser and the opening of angles. Secondary outcome measures are pain and inflammation associated with laser procedure, lens and corneal endothelial changes.

NCT ID: NCT01017874 Completed - Clinical trials for Non Small Cell Lung Cancer

A Study of Alimta/Cisplatin/Gefitinib for Asian Non-smoking Participants With Non Small Cell Lung Cancer

Start date: November 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare two different approaches to treating non-small cell lung cancer (NSCLC) in East Asian never-smoker participants. Half of the participants will receive chemotherapy (pemetrexed/cisplatin) followed by an oral anti-cancer agent (gefitinib) and the other half of the participants will receive only the oral anti-cancer agent (gefitinib).

NCT ID: NCT01014247 Completed - Electrocardiography Clinical Trials

Influence of Moxifloxacin on QTc Interval in Healthy Subjects for Positive Control Validation

Start date: November 2009
Phase: Phase 1
Study type: Interventional

The aim of this study is to investigate the effect of moxifloxacin on the QT interval in order to gain information on the validity of results that will be collected during another clinical study testing riociguat in patients with pulmonary arterial hypertension (PATENT-1 study).

NCT ID: NCT01014208 Completed - Clinical trials for Lymphoma, Large-Cell, Diffuse

Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma

ORCHARRD
Start date: March 2010
Phase: Phase 3
Study type: Interventional

This study is being conducted to compare the efficacy and safety of ofatumumab in addition to salvage chemotherapy versus rituximab in addition to salvage chemotherapy in CD20 positive DLBCL subjects relapsing, or with persistent disease, after first-line treatment with rituximab combined with an anthracycline-based chemotherapy regimen and be eligible for ASCT.

NCT ID: NCT01012973 Completed - Clinical trials for Retinal Vein Occlusion

Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)

GALILEO
Start date: October 2009
Phase: Phase 3
Study type: Interventional

To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion

NCT ID: NCT01010113 Completed - Infant Nutrition Clinical Trials

Effects of a Synbiotics-containing Starter Formula on Infant Growth

Start date: November 2009
Phase: N/A
Study type: Interventional

In this study the investigators want to evaluate the satiety of two infant formulas, one containing prebiotics and the other containing synbiotics. Rate of weight gain, a proxy measurement for the healthy development of an infant, will be assessed in both groups and compared to the growth observed in the WHO Child Growth Standards in order to demonstrate non inferiority.